Stand alone swage dial assembly

ABSTRACT

A semi-automated machine for singulating individual surgical needles from an bulk supply and attaching a suture to the surgical needle is described. Each of the surgical needles has a suture receiving opening formed therein for receiving a suture. The machine includes a needle singulation station, a precise positioning station, a suture feeding station, a swage station, a pull-test station and an off-load station. A universal gripper mounted on a rotary indexing device automatically receives each individual needle in a predetermined orientation and conveys the needle for sequential processing from station to station to form the needle-suture assembly. The rotary indexing device includes two coaxial cam dials that provide rotation and reciprocation of the universal gripper, and an off-set drive is provided at two locations for laterally off setting the radial reciprocation of the universal gripper. This off set is necessary to enable the universal gripper to place and receive needles in a fixed jaw having a die opening or needle gripping opening formed therein. A swage station is provided for swaging the needle to close the suture receiving opening about the suture to secure said suture thereto and form therefrom a needle and suture assembly. A final off-load station provides an apparatus for assembling a predetermined number of need-suture assemblies in a bundle for subsequent packaging.

FIELD OF THE INVENTION

The present invention relates generally to machines for automaticallyswaging needles, such as surgical needles to a suture, and morespecifically, to an apparatus that automatically swages, tests, andcreates bundles of armed sutures, i.e., needles having a suture strandof predetermined length attached at one end thereof, for subsequentpackaging.

DESCRIPTION OF THE PRIOR ART

This application describes in detail an improvement of a portion of theapparatus disclosed in a series of U.S. Patents, of which U.S. Pat. No.5,473,810 entitled "Needle-Suture Assembly and Packaging System" andU.S. Pat. No. 5,473,854 entitled "Machine for the Automated Packaging ofNeedles and Attached Sutures and Method of Utilizing the PackagingMachine," are typical. All of these patents are assigned to the assigneeof the present invention.

U.S. Pat. No. 5,473,810 discloses in FIGS. 19A and 19B a set of swagedies that were machined and tested with the apparatus, but were not usedin the commercial version of the device because of problems associatedwith placing and retrieving the needle in the cut out portion of thefixed die. When this machine went into commercial production, it did notuse these dies, but rather a die which was flat on the fixed swage dieside and arcuate or rectangular on the moveable die side. The presentapplication discloses an improved swage dial and off set assembly thatwill allow commercial use of the dies illustrated in the abovereferenced Figures.

The automatic needle and suture threading machine described in U.S. Pat.Nos. 5,473,810 and 5,473,854 is a highly automated machine intended forhigh volume production and packaging of needles and sutures wherein20,000 to 40,000 needles and sutures are to be produced in a single run.

SUMMARY OF THE INVENTION

The present application describes an improved swage dial assembly forthe swaging of needles to sutures fed and cut to length by theapparatus, together with improvements in the operation of the apparatus.

The improved swage dial assembly of the present application includes animproved cam dial, an improved universal needle gripper and an off setassembly that enables placement and retrieval of needles in a cut outdie portion of a fixed swage die.

The present invention is also directed to improvements for a stand aloneswage machine that is particularly adapted to assist in thesemiautomated singulation of surgical needles to enable subsequentautomated handling of the needle, automatic swaging, automatic pulltesting of the combined needle and suture (armed sutures), and bundlingof the armed sutures for future packaging.

It is an object of the present invention to provide a machine which willefficiently handle small batches or production runs on needles and toefficiently handle premium needles and super sharp cutting edge needlesin an efficient manner without blunting the cutting edge of the needle,while bundling the same for future packaging.

It is another object of the present invention to provide a machine whichis flexible in operation and enables quick changeovers betweenproduction lots and which minimizes the number of change parts requiredto migrate from one size needle or suture to another.

It is another object of the present invention to provide a machine whichwill handle odd runs or "doctors' specials" as they are referred to inthe trade, where a particular surgeon expresses a preference for anunusual combination of needle type or size and suture material.

It is an objection of the present invention to provide a needlethreading and swaging apparatus for attaching a suture to a surgicalneedle having a suture receiving opening formed therein, wherein theapparatus includes a frame which supports a drive means for a swagedial. The drive means includes a first and a second intermittent drive,each of which intermittent drives have a drive period and a dwell periodto provide intermittent advancement of the swage dial. The machineincludes a swage dial and a cam dial mounted for rotation about a commonfirst axis of rotation, with the swage dial supported by and mounted forrotation on a first drive shaft which rotates about this single firstaxis of rotation. This first drive shaft is driven by said firstintermittent drive to provide intermittent advancement of the swagedial.

It is another object of the present invention to provide a plurality ofuniversal gripper mounted on said swage dial for successively receivingan individual one of a plurality of precisely positioned needles at afirst predetermined location and indexing each of said individualsuccessive needles in a predetermined orientation from said firstpredetermined location through successive locations for sequentialprocessing at subsequent predetermined locations, each of said universalgrippers having a cam follower which cooperates with said cam dial toprovide radial reciprocation of said universal grippers with respect tosaid swage dial in response to rotation of said cam dial.

It is another object of the present invention to provide an improvedswage dial having an off set motion for the universal grippers thatenables the grippers to place and retrieve needles held in a swagedevice having a swage die opening formed in a fixed swage die.

It is another object of the present invention to provide universalgrippers which are rotated by said swage dial to each of saidpredetermined locations and reciprocated in and out of an operativeposition by said cam dial at each of said plurality of predeterminedlocations.

Finally, it is an object of this invention to provide a rotating arrayof needle collection buckets that enables collection of a predeterminednumber of needle and suture assemblies (armed sutures) that are bundledby the present machine for subsequent packaging in machines such as thattypified by U.S. Pat. No. 5,487,212 or the machine described in U.S.Ser. No. 521,831, entitled "Single Suture Automated Packaging Machine",both of which are assigned to the assignee of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic top view of the needle threading and swagingsystem incorporating a semi-automatic needle sorting and singulatingtable for feeding individual needles to a universal gripper mounted on arotary swage dial, an automatic swaging station, an automatic pull-teststation, and an armed suture off-load and bundling station.

FIG. 2 is a diagrammatic view of an edged needle that is typical of theneedles to be singulated and swaged according to the present invention.

FIGS. 3(a) through 3(c) together form a flow diagram illustrating theprocess for the needle threading and swaging system of the presentinvention.

FIG. 4 is an elevation side view of the present invention illustratingan operator station, a control computer, portions of the robotichandling device, and the swage drive of the present invention.

FIG. 5 is a top plan view of the present invention with the operatorsafety guards illustrated in FIG. 4 removed.

FIG. 6 is a detailed elevation side view of the present invention fromthe opposite side as illustrated in FIG. 4, with the operator safetyguards removed.

FIG. 7(a) is an elevation view of a portion the apparatus illustratingthe inventive drive for the cam dial and swage dial of the presentinvention.

FIG. 7(b) is a side view of the drive for the swage dial illustrated inthe elevation view of FIG. 7(a).

FIG. 8 is a detailed and partially cross section view of the drive forthe swage dial taken along section lines "A"--"A" in FIG. 7(a) whichillustrates a universal gripper ready to reciprocate outwardly toreceive an oriented surgical needle from a precision conveyor.

FIG. 9 is front elevation view of the suture drawing and cutting towerassembly used in the present invention.

FIG. 9(a) is top plan view of the suture tipping assembly used in thesuture drawing and cutting apparatus of the present inventionillustrated in FIG. 9.

FIG. 9(b) is front elevation view of the suture tipping assemblyillustrated in FIG. 9(a) and used in the suture drawing and cuttingapparatus of the present invention.

FIG. 10(a) is a top view of the swage dial assembly 150 comprising aswage dial plate 110 having four universal gripper stations 145a,b,c,dmounted thereon.

FIG. 10(b) is cross-sectional view of the four station swage dialassembly 150 showing universal gripper 155 in a retracted position.

FIG. 10(c) is cross-sectional view of the four station swage dialassembly 150 showing universal gripper 155 in an extended position.

FIG. 11(a) is detailed top view of the cam dial assembly 120 having camdial plate 125 with cam follower 165a in a retracted position within camtrack 160a.

FIG. 11(b) is cut away top view of the cam dial plate 125 showing camfollower 165a in an extended position within cam track 160a.

FIG. 12 is a top plan view of the swage assembly and off-set assembly ofthe present invention used for swaging the needles for sutureattachment.

FIG. 13 is an enlarged isometric view of a suture gripper assemblyhaving gripper arms shown in their open (dotted lines) and closed(suture gripping) positions.

FIG. 14(a) is top plan view of the universal gripper and slide assemblyused in the present invention, illustrating in dotted lines the variousoperating components thereof.

FIG. 14(b) is partially cross-sectioned side view of the universalgripper and slide assembly illustrated in FIG. 14(a).

FIG. 14(c) is a partially hidden front view of the universal gripperillustrated in FIG. 14(a) illustrating in dotted lines the actuatingmechanism used to open the jaws of the universal gripper.

FIG. 15(a) is front face view of the universal gripper showing asurgical needle about to be placed in the swage dies of the presentinvention.

FIG. 15(b) is front face view of the universal gripper and a surgicalneedle with the universal gripper in a relaxed engagement, with theneedle gripped by the swage dies of the present invention.

FIG. 16 is a partially cross section top view of the needle stripperassembly used in the present invention.

FIG. 17 is a top plan view of the needle bundling station of the presentinvention illustrating a plurality of compartments, each of whichreceives a predetermined number of needle and suture assemblies.

FIG. 18 is an elevation view of a needle bucket for the apparatusillustrating radial reciprocation of the needle bucket of the presentinvention.

FIG. 18(a) is a front view of the needle bucket for the apparatusillustrated in the elevation view of FIG. 18.

FIG. 18(b) is a top view of the needle bucket for the apparatusillustrated in the elevation view of FIG. 18.

FIG. 19(a) is a top plan view of the fixed and moveable swage dies ofthe present invention.

FIG. 19(b) is an enlarged view of a portion of the apparatus illustratedin FIG. 19(a) with a needle positioned therein before swaging.

FIG. 19(c) is a top plan view of portions of the suture guides of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is directed to improvements in a stand alone swagemachine that is particularly adapted to assist in the semi-automatedsingulation of surgical needles to enable subsequent automated handlingof the needle, automatic swaging, automatic pull testing of the combinedneedle and suture, and bundling for future packaging.

The present application describes improvements in the swaging assemblythat swages needles to sutures, together with improvements in theoperation of the apparatus. The present invention enables the swaging ofneedles in symmetric dies, even when one of the dies is fixed inposition.

This application describes in detail an improvement of a portion of theapparatus disclosed in U.S. Pat. No. 5,473,810 entitled "Needle-SutureAssembly and Packaging System" and U.S. Pat. No. 5,473,854 entitled"Machine for the Automated Packaging of Needles and Attached Sutures andMethod of Utilizing the Packaging Machine," both assigned to theassignee of the present invention. The present invention includes animproved drive train for the swage dial which is similar to the swagedial used in the machine described in the aforesaid patents.

The automatic needle and suture threading machine described in U.S. Pat.No. 5,473,810 is a highly automated machine intended for high volumeproduction and packaging of needles and sutures wherein 20,000 to 40,000needles and sutures are to be produced in a single run.

The machine described in this application is designed to efficientlyhandle small batches or production runs on needles and to efficientlyhandle premium needles and super sharp cutting edge needles in anefficient manner. It is intended to provide flexibility in operation anda quick changeover between production lots and to minimize the number ofchange parts required to migrate from one size needle or suture toanother.

The present invention is also intended to handle odd runs or "doctors'specials" as referred to in the trade, where a particular surgeonexpresses a preference for an unusual combination of needle type or sizeand suture material.

Needle and suture assemblies (armed sutures) are swaged by the presentmachine for subsequent packaging in machines such as that typified byU.S. Pat. No. 5,487,212 or the machine described in U.S. Pat. No.5,664,404, entitled Single Suture Automated Packaging Machine, both ofwhich are assigned to the assignee of the present invention.

The present invention minimizes the handling of the needle and istherefore particularly adapted for the automated handling of premiumneedles and cutting edge needles such as the needle illustrated in FIG.2.

As illustrated in FIG. 2, the needle 39 includes a ground or cuttingedge portion 40 and is illustrated with an attached suture 42 which hasbeen attached by swaging as indicated at 44. The suture 42 may be of anypredefined length, but is commonly provided in lengths that aremultiples of nine inches (18, 27 and 36 inch suture sizes areparticularly common).

Generally, in the needle threading and swaging system of the presentinvention, parallel operations take place simultaneously at a pluralityof different stations to ensure that approximately forty to sixty(40-60) armed surgical needles are assembled and discharged per minute.For instance, as shown in FIG. 1, a semi-automatic needle sorting andsingulating station 50 assists an operator in sorting and singulatingindividual needles to a pair of translucent indexing conveyors 102,104where the singulated needles are imaged by a vision system, selected bya computer, and transferred from the translucent indexing conveyors102,104 to a precision indexing conveyor 106 by a robotic gripper 108.The precision indexing conveyor conveys precisely oriented surgicalneedles to a precise positioning station 100 to be sequentially receivedby a plurality of grippers mounted on the rotary swage dial 150. Therotary swage dial then rotates counter-clockwise as shown by the arrowin FIG. 1, to index each needle to the automatic swaging station 200where the suture material is cut, inserted into the needle, andautomatically swaged thereto. A suture drawing and cutting station 300pulls, tips, cuts and inserts the suture into the needle to be swaged.The needle is swaged and then, the rotary swage dial 150 rotates toindex the armed suture to the automatic pull-test station 400 where eacharmed needle is pull-tested to ensure that the minimum and/ordestructive pull-test requirements of the medical profession, are met.Finally, the rotary swage dial indexes the pull-tested armed needle tothe off-load station 500 where the surgical needle and suture assembliesare handed off for suture bundling for subsequent packaging at anotherlocation.

FIGS. 3(a) through 3(c) are block diagrams which illustrate theautomatic needle threading and swaging process of the instant invention.For instance, at the needle singulating station 50, needles are firstloaded onto a flat operator work surface at 10, singulated by theoperator, and then automatically and individually fed at step 11 to oneof the translucent indexing conveyors 102,104. The needles are imaged atstep 12 and then evaluated with respect to orientation and position by avision tracking system at step 13, picked up by a robot apparatus atstep 14, transferred to a precision conveyor 106 for positioning by therobot apparatus 108 at step 15, and finally conveyed to a load station100 where the needles are precisely positioned at step 16 andtransferred to a universal gripper located on a rotary swage dial 150for subsequent transfer to the swaging station 200 indicated at step 25.A detailed explanation of the apparatus used to carry out each step willbe explained in further detail hereinbelow.

Simultaneous with the needle sorting process described above withrespect to steps 10 through 25, an automatic suture cutting processtakes place at the suture station 300 as shown in FIGS. 3(a) and 3(c)with respect to steps 18 through 28. Indefinite length suture materialis supplied in various spools and configurations that may carry up to5000 yards of material. This is indicated at step 18 in FIG. 3(a), wherethe suture material is loaded into a payoff assembly. A tension constantfor the suture to be drawn is downloaded as indicated at step 19. Adrawing tower apparatus includes grippers that alternately draw lengthsof the suture material from the spool to enable cutting thereof whichlengths are predetermined at step 20.

While the material is being drawn, it may require extra treatment orprocessing. For instance, as described in detail below, it may bedesirable to heat the suture material under tension at the area whichwill become the suture tip in order to stiffen the material tofacilitate the positioning thereof within the suture receiving openingof a surgical needle. Thus, at step 20, heat may be applied to a portionof suture material. In the preferred embodiment of the invention theheating step is performed upstream of the drawing and cutting apparatusto enable the suture to partially cool and harden before cutting. Atstep 21 of the block diagram of FIG. 3(a), the suture material isclamped and gripped by the servo grippers, and at step 22, the suturestrand is drawn to a predetermined length and positioned for insertionwithin the suture receiving opening of the needle for swaging. As thesuture is positioned for insertion, a second suture clamps the suture ata position which will hold the indefinite length end at step 23, and thesuture is cut at step 24 to separate the suture of predetermined lengthfrom the indefinite length suture.

After a surgical needle is indexed to the swaging station 200 asdescribed above, the universal gripper positions the needle in aprecisely oriented position at the swage die opening formed at the endsof two swaging dies of a swage assembly as indicated as step 26 in FIG.3(b). Simultaneously, the suture strand is drawn along a suture axis toregister a tip thereof for insertion within the suture receiving end ofthe needle. Next, at step 27, the gripper assembly at the drawing towerinserts the tip of the suture strand within a lower funnel guide foraccurate positioning within the suture receiving opening of the needlethat is aligned with the suture drawing axis. At step 28, the swagecylinder is activated to automatically swage the suture to the needle.The universal gripper is actuated to grip the needle, and then retractedon the rotary swage dial as shown as step 29 and indexed to a pull-teststation 400 at step 30 so that minimum pull-testing at step 32 ordestructive pull-testing at step 34 may be performed.

Depending upon the results of the minimum pull-test, the needle andsuture assembly will either be indexed by the rotary swage dial to theoff-load station 500 where the armed needle will be bundled if thepull-test requirements are met (as shown as step 32 in FIG. 3(c)), or,will be discharged at the pull-test station if the needle fails theminimum pull-test (as shown as step 35 in FIG. 3(c)). The destructivepull-test always renders the needle incapable of further processing sothe needle is automatically discharged at the pull-test station 400 asindicated at step 35 in FIG. 3(c). Finally, as shown as step 33 in FIG.3(c), needle and suture assemblies passing the minimum pull test areconveyed to an off-load station 500 where the individual armed suturesare bundled for subsequent packaging and sterilization.

A detailed explanation of the apparatus used to carry out each step inthe suture cutting process will be explained in further detailhereinbelow.

Overview of the Apparatus

FIG. 4 is an elevation view of one side of an apparatus constructedaccording to the teachings of the present invention, and FIG. 5 is a topplan view of the apparatus with the safety guards removed. FIG. 6illustrates the apparatus from the opposite side as FIG. 4. FIGS. 4-6are used in the following descriptive overview of the apparatus. Thisapparatus includes a singulation area or table 50 to assist an operatorin singulating needles that are deposited to the translucent conveyors102,104, one of the conveyors 104, being depicted in FIG. 4. Theoperator work station includes a platform 51 for operator seating andguard rails 52 for operator safety. Safety guards 54 are also providedaround the machine for safety purposes.

Each of the needles singulated by the operator are dropped throughopenings 48,49 by sliding the needle along the table surface 50. Thisstep avoids the needle to needle contact inherent in the vibratory feedbowls illustrated in U.S. Pat. No. 5,473,810 and thus substantiallyreduces the risk that premium needles or cutting edge needles will beblunted by needle contact. As each needle is dropped, it lands at anintermediate staging location, and at an appropriate interval, aftereach index of the indexing conveyor, the needles is blown by a puff ofair to the translucent indexing conveyor, with needles dropped throughopening 48 being transferred to translucent indexing conveyor 102 andneedles being dropped through opening 49 being transferred totranslucent indexing conveyor 104.

The needles thus transferred are indexed forward to imaging stations101,103 wherein a back light provides a high contrast image of theneedle against a white background for imaging purposes. The indexingconveyors 102,104 are indexed approximately 2 inches at each index. Bylimiting the incremental advancement the image processing is step isenhanced, and problems associated with inertial loads on the needles onconveyors 102,104 are minimized. If the indexing conveyors 102,104 areaccelerated too quickly, the needle will remain in its drop position andnot be advanced forward, and conversely, if the needle is moving on theconveyor, and the conveyor is stopped too quickly, the needle willcontinue to travel after the conveyor is stopped. The present apparatusseeks to avoid either of these situations by minimizing the amount ofindex at each incremental step while still providing enough movement toprovide an adequate supply of needles to the apparatus.

The needle singulating apparatus illustrated provides a single needle ateach drop point which substantially enhances the accuracy of the visionsystem and minimizes needle returns that might otherwise be necessaryfor overlapping or nested needles that were either not imaged, orselected by the computer control means 39 for transfer by the roboticapparatus 108.

The needles deposited on the translucent indexing conveyor 104 areimaged by a vision system 105 and these images are processed by acomputer control means 46 to identify the orientation and X,Y coordinatelocation of the needles. Determining the X,Y coordinates alone is notenough in the needle swaging environment inasmuch as the roboticapparatus needs to determine, in the case of a symmetrically formedcurved needle, which end is the barrel end and which end is the cuttingend in order to properly place the needle for subsequent automatedhandling. After both the orientation and location have been determined,a robotic apparatus 108 picks the needles from the translucent conveyors102,104 and places them on a precision indexing conveyor 106. Theprecision conveyor 106 includes a plurality of "boats" 70 which areparticularly adapted to provide precision positioning of the needle. Therotary swage dial 150 includes a drive motor 140 and first and secondindexing transmissions 142,144 which are used to drive the swage dial ina manner as will be hereinafter explained in detail.

The needles transferred by the robotic apparatus 108 are transferred sothat the butt end of the needle 44 is engaged by gripping jaws on theconveyor boats 70 of the precision conveyor 106. While the butt end islocated and gripped by the robotic apparatus 108, at the point of pickupit may be oriented in either direction of curvature. For particularlysmall needles a fixed post may be provided for the robotic apparatus touse in correcting the orientation of curvature. For larger needles, aneedle plow 109 is used so that the direction of curvature for each ofthe needles is uniform. As illustrated in FIG. 5, the apparatus alsoincludes a prepositioner 107 which is adapted to approximately locatethe butt end of the needle and an adjustable hard stop assembly atstation 100 that precisely registers the butt end of the needle to anaccuracy of 0.001 inches.

The needle singulation apparatus, and the operation of the indexingconveyors 102,104, the robotic apparatus 108 and the precision conveyor106 is more fully described and claimed in U.S. Ser. No. 08/847,113,entitled "Semi-Automated Needle Feed Method and Apparatus," thedisclosure of which is incorporated herein by reference thereto.

After the needle has been received at the precise positioning station100, it is gripped by one of the universal grippers located on the swagedial mechanism 150 to be indexed through a plurality of stationsincluding a swage station 200 wherein a suture of definite length is cutfrom a suture spool of indefinite length at station 300 and insertedinto the needle at swage station 200 for permanent assembly thereto.After swaging, the needle is advanced to the pull-test station 400 fortesting of the needle suture bond, and then indexed to a bundlingstation 500 wherein a plurality of buckets are circumferentiallyarranged on a rotating turntable to receive a predefined number ofneedles and sutures in each bundle.

FIG. 6 illustrates the apparatus of the present invention from theopposite side of the machine illustrated in FIG. 4 and includesbreakaway portions to more particularly illustrate portions of theprecision conveyor apparatus and the suture drawing and cutting station300. As illustrated in FIG. 6, a spool of suture material 302 is mountedon a convenient location and the indefinite length suture material 304is fed to the suture drawing station through a pretensioning apparatus306, a tensioning roller 314 having a computer controlled tensionconstant which may be selectively downloaded from the computer controlmeans 46 to match the suture material 304 being handled, and a knotdetector 310 which may be used to provide a knot presence signal to thecontrol computer 46 to reject that length of suture after swaging to aneedle. From the knot detector 310 the suture strand 304a is fed througha tipping station 330 which heats the suture strand to a predeterminedtemperature to assist in tipping and cutting the suture for insertioninto the surgical needle. From the heating and tipping station 330, thesuture material is passed to the bottom of the machine to a turnaroundroller 335 where it is grasped by first and second suture clamps whichadvance the suture material 304a in a hand over hand manner. Asillustrated in FIG. 13, clamp 331 includes a traveling carriage 333which reciprocates up and down frame member 338 by means of a timingbelt which is secured to the carriage at 368. A pneumatic actuator 318includes first and second clamps 365a,365b and first and second grippingsurfaces 366a,366b which clamp the suture material therebetween.

In a first cycle of operation, clamp 331 draws the suture of indefinitelength to a suture insertion point immediately adjacent the swage platesof the swaging station and then dwells while a second suture clampclamps the indefinite suture length below the suture cutter 334(illustrated in FIG. 9). After the second suture clamp has engaged thesuture, the cutter 334 is actuated to cut the suture and the tip end ofthe suture 358, illustrated in FIG. 13 is inserted into the needle asillustrated in FIG. 15(b). The tip end of the suture 358 is positionedbelow a funnel dye formed in suture alignment plates 270,271 whichreciprocate immediately below swage plates 273,374. After the suture tipend 358 has been inserted into the barrel end 44 of needle 39, the swagestation is actuated driving the swage plate 273 against swage plate 274to swage the suture tip 358 in the surgical needle 39.

Suture Drawing and Cutting

FIG. 9 illustrates a front elevational view of one designed embodimentof a servo tower 300, similar to that shown in FIGS. 2-6, and shows thesuture path therethrough. Suture 304 is pulled off one end of a supplyroll 302 mounted to one side of the servo tower, through the center ofan annular guide disc 305, and into a mechanical tensioner 306. Themechanical tensioner can comprise a stationary guide frame 308 and apivotally mounted guide frame 310, pivotally mounted about a pin 312 atthe lower end of the stationary guide frame. Each of the stationaryguide frame and the pivotally mounted guide frame has a series of spacedguide elements, each with a central guide aperture therein, which arealternately interleaved, such that the spaced guide elements of thepivotally mounted guide frame alternate with the spaced guide elementsof the stationary guide frame. The pivotally mounted guide frame 310 isspring biased about the mounting pin 312 to rotate the top thereof awayfrom the top of the stationary guide frame, such that the sutureextending between the alternating stationary guide frame elements andthe pivoted guide frame elements is placed under tension while beingpulled therethrough.

The suture then travels over idler roller 326, and extends to and iswrapped twice around a tension roller 314 which is mounted on one end ofa torque motor 316, (illustrated in dotted lines in FIG. 9) whichapplies a given tension to the suture as it is pulled through the servotower by the first and second gripper assemblies 331, 332. The grippingassemblies alternate in a hand over hand advancement as previouslydescribed in U.S. Ser. No. 08/181,595, entitled "Suture Cutting System,"the disclosure of which is incorporated herein by reference thereto.Each different suture size and material should have a different tensionapplied thereto as it is drawn through the apparatus. The torque motor316 provides a different tension force for each different suture sizeand type, and the specific tension force (in grams per volt to beapplied by the torque motor) is downloaded from a computer program ateach suture batch changeover. The proper tension is important forseveral operations described herein, and is particularly important forthe cutter assembly to operate while providing a clean neat cut withouta broom effect.

The suture then extends to an out-of-suture sensor positioned at 317,and then through a knot detector 320. The suture 304 then travels to asecond idler roller 328 to change direction again, from which the suture304 extends vertically downwardly through a heated tipping assembly 330,which heats and ultimately stiffens a small length of the suture, atwhich small length the suture is subsequently cut and the cut tip isinserted into and swaged to a needle.

The suture 304 then extends downwardly from the tipping assembly to alarge idler roller 335 mounted near the bottom of the machine having anappropriately 7 inch diameter, at which the suture reverses directionand travels vertically upwardly to the first and second gripperassemblies 331, 332, to the suture cutter assembly 334 and a sutureswaging During the insertion operation, the cut suture end is guided bya funnel shaped aperture 270(a),271(a) in a suture guides 270,271 intothe aperture in the end of a needle, after which a moving anvil 273 ismoved relative to a stationary anvil 274, of a swage die, to swage andattach the needle to the suture.

In this embodiment, after initialization, one gripper assembly will bein a home position, 2" below the face of the swage die mounting surface,allowing a 2.03" movement from the home position to an insert position.A proximity switch is located on each tower at 2" below the face of theswage die mounting surface to set the home position during aninitialization procedure.

Assuming that the machine is being initially set up to cut a desiredlength of suture, the cutter assembly 334 will be moved to apredetermined vertical position in the swaging machine by operation ofthe handcrank attached to gearbox 341. This is done by aligning apointer for the cutter assembly with a vertical scale 356 positioned onthe side of the swaging machine, similar to the vertical scale 357 shownabove for the tipping assembly.

The cutter assembly includes a proximity switch thereon, and during aninitialization procedure, the position of a gripper assembly is detectedby the proximity switch, and that position is set in memory to set theservo gripper bottom position 332 during subsequent normal operation ofthe machine. The tipping assembly is also moved to an appropriateposition in the machine as described hereinbelow.

FIG. 9 shows the right gripper 332 positioned slightly below the cutterassembly 334 so that the indefinite length strand will be gripped whenthe definite length swaged strand is cut. Thus, the upper left gripper331 now grips the suture material 304 having a tipped end 358 and it nowbecomes the lead gripper. The next cycle begins with the lower gripper332 vertically drawing the material 304 along the height of the drawingtower 300 for the long stroke to position the next strand to be cut forinsertion within the surgical needle.

During this operation, assume that the upper gripper assembly 331 hasjust moved to its home position. At the home position, the gripperassembly 331 stops and waits a predetermined time, during which a needleis preclamped in an insertion position in the swaging station 200, andthen moves to the insert position. The following operations are thenperformed substantially simultaneously. The bottom gripper assembly 332closes, a tipping operation is performed simultaneously at the tippingassembly 330, and the swage station is simultaneously actuated to swagethe needle end around the suture, attaching it thereto. Thereafter, thecutting assembly 334 is activated, cutting in the tipped area to cut thesuture to the given length. Thereafter, the upper gripper assembly 331opens, and the assembly 331 returns to the bottom position, andsimultaneously therewith the lower gripper assembly 332 moves up to thehome position, and the cycle is then repeated.

After removal of the swaged needle and attached suture length from theapparatus, it is subjected to a sterilization operation, during whichthe suture length incurs some shrinkage. Accordingly, the cut lengths ofsuture must be cut to lengths slightly longer than their desired(orlabel) final lengths to compensate for such shrinkage.

The following table gives, for silk suture, in the left column thecommercial(or label) suture length, in the middle column the low servoposition of the low gripper assembly below the face of the swage diemounting surface, and in the right column the cut length of suture priorto shrinkage. VICRYL shrinkage during sterilization is approximately 3%of the table values for silk.

    ______________________________________    18"        servo--16.51                          allowed for 18.350"    27"        servo--25.51                          allowed for 27.380"    30"        servo--28.51                          allowed for 30.380"    36"        servo--34.51                          allowed for 36.380"    ______________________________________

As described above, after heating of a predetermined length of suture atthe tipping assembly, the suture must cool to allow setting andhardening of the suture material prior to cutting of the suture at thehardened length and insertion of the cut stiffened end into a needle.This cooling of the suture is provided in this embodiment by allowing adiscrete number of machine cutting cycles to occur between tipping ofthe suture and cutting of the suture. This is provided by allowing apredetermined long length of suture travel between the tipping assemblyand the cutter assembly. Hence, the suture tipping assembly 330 ispositioned near the top of the servo tower, and after heating thereat,the suture travels to the bottom of the machine, around the large idlerroller 335, and then back upwardly to the cutter assembly 334. The largediameter of the idler roller 335, relative to the other idler rollers326, 328, is provided because the small length of suture which has beenheated at the tipping assembly 330, has begun to harden and set by thetime the heated section reaches the large idler roller. The largediameter thereof facilitates the suture to travel therearound withoutpicking up a permanent curved set from the large idler roller, as it isdesirable for the suture to be straight, without any curve, when it issubsequently cut and inserted into a needle. The idler rollers 326 and328 typically have a 0.5 inch diameter, whereas the large diameterroller 335 has a diameter preferably greater than 6.0 inches,approximately 7.0 inches in one embodiment.

The operation of the machine depends upon a discrete whole number ofmachine cutting operations to be performed between the tipping andcutting operations. Accordingly, for each different length of cutsuture, the tipping assembly 330 must be positioned at a differentpredetermined position within the machine for the tipped section ofsuture to be precisely and correctly positioned at the cutter assembly334 after a given number of machine cycles.

The following table gives in its columns, proceeding from left to right,the label suture length, the actual cut suture length, the number ofmachine cycles or increments provided between tipping and cutting, thetotal travel length of the suture between tipping and cutting, thetipping assembly vertical position above the table top, and the tippingassembly scale pointer position above the table top (explained ingreater detail hereinbelow).

    ______________________________________    SUTURE LENGTH              ABOVE TABLE TOP    LABEL ACTUAL   INCREMENTS TOTAL  TIPPER C                                            POINTER    ______________________________________    18 IN.          19 IN.   6          114 IN.                                     27.64 IN.                                            25.89 IN.    27 IN.          28 IN.   4          112 IN.                                     25.64 IN.                                            23.89 IN.    30 IN.          31 IN.   4          124 IN.                                     37.64 IN.                                            35.89 IN.    36 IN.          36.25 IN.                   3          108.75 IN.                                     22.39 IN.                                            20.64 IN.    ______________________________________

FIG. 9(b) illustrates an enlarged front elevational view of the suturetipping assembly at which a small length of the suture is heated tostiffen the suture material after subsequent cooling thereof, inpreparation for cutting a given length of the suture and inserting thelead cut end of the suture into the end of a needle for swaging thereto.FIG. 9(b) illustrates the movement of the tipping assembly 330 along avertical scale 357 provided adjacent to the tipping assembly 330. Thevertical position of the tipping assembly in the machine is adjustableby a handcrank 360 and precision lead screw 361, similar to thepositioning mechanism for the cutter assembly as described hereinabove.As the handcrank is rotated, the vertical position of the tippingassembly 330 in the machine is changed, and is precisely positioned byreading a pointer 359 attached to the tipping assembly on the scale 357.A chart is provided for the machine which gives, for each desired lengthof suture, the appropriate position for pointer 359 of the tipperassembly 330 on the vertical scale 357, and a similar position for thecutter mechanism 334 on the vertical scale 356.

In this embodiment, the position of the cutting mechanism along thedrawing axis is continuously adjustable to provide an infinite number ofpossible different lengths of cut suture. For each different cuttingposition of the cutting mechanism, the tipping mechanism is adjustablypositioned at a different predetermined position in the apparatus toprovide for the tipped section of suture to be precisely positioned atthe cutter mechanism for a discrete number of machine cycles.

In an alternative embodiment which does not have this infiniteadjustment feature, several standard lengths of suture are accommodatedby several standard positions which are fixed in the machine by pinswhich secure the cutter mechanism to the machine frame by pin receivingholes in the machine at the standard positions. For example, the cuttermechanism might be moved to a position for cutting 18" sutures and besecured to the frame by the placement pins being inserted into the pinreceiving holes in the machine for 18" sutures. The cutter mechanismmight also be moved to positions for cutting 27", 30", or 36" sutures bymoving the placement pins to the pin receiving holes in the machineprovided for those length sutures. Each different position can have aseparate proximity switch provided therefor, which indicates the cuttingmechanism position to the controller, which then downloads theappropriate servo gripper bottom position. The appropriate tippingmechanism position is known for each different cutter mechanismposition.

FIGS. 9(a) and 9(b) illustrate a heater 362 in the tipping assembly 330and the vertical movement of the suture 304(a) down (front view, FIG.9(b)) and through (top view, FIG. 9(a)) a suture tipping aperture 364,FIG. 9(a), positioned on the right side of the tipping assembly. FIG.9(a) illustrates further details of the flow of heated air through thetipping assembly and its control to selectively heat and tip the suture.As described previously, the tipping assembly 330 is mounted near thetop of the machine so that it takes a discrete number of machine cyclesfor the suture to reach the cut position. This gives the tipped areatime to cool down before the cutting and insertion operations. Thetipping assembly operates by flowing air supplied at a regulatedpressure through an inlet air duct 366 at a regulated flow rate, in oneembodiment 195 CFH (Cubic Feet per Hour), over a heater coil mountedwithin an outer heater casing 368. Air is supplied to a flowmeter at aregulated pressure required to maintain 195 CFH of air flowing over theheater coil. A thermocouple 370 is positioned in the air flow at thedischarge end of the heater casing 368, to monitor and control the airtemperature through a controller in a programmable logic controller(PLC). The tipping assembly 330 is operated at various temperaturesbetween 200° F. and 550° F. depending upon the particular suturematerial to be run. The particular temperature is a down loadedparameter from an operating program at each suture batch changeover. Thetipping assembly guides the suture and provides a 2.000" long heatingaperture 364 for the tipping length.

The constant flow of heated air at the outlet of 368 flows either 1)through the heating aperture 364 in which the suture 304 isintermittently stopped and positioned during a tipping operation, or 2)alternatively the heated air is dumped into the surrounding atmospherethrough a diverter channel 372, illustrated in FIG. 9(b). The flow ofhot air is controlled by an air cylinder 374, under control of asolenoid 376, which controls the flow of actuating air through air tubes378, 380. The air cylinder 374 controls the position of a retractableslide element having a flow aperture therein which is selectivelypositioned in front of either 1) a channel into the heating aperture 364or 2) the diverter channel 372, depending upon the position of theslider element which is controlled by an air cylinder.

As an example, the following control parameters have been establishedfor heat tipping of Braided VICRYL sutures sizes 1, 0, 2/0, 3/0 and 4/0.The suture tension refers to the tension force in grams which thetension roller 314 and torque motor 316 apply to the suture as it isbeing drawn through the machine by the grippers.

    ______________________________________             Tipping Temp.                         Tipping Time                                     Suture Tension    Suture Size             +/-25 deg.  +/-25 Ms    +/-25 Grams    ______________________________________    4/0      375 F.      380         275    3/0      395 F.      380         275    2/0      410 F.      380         275    0        425 F.      380         275    1        435 F.      380         275    ______________________________________

As a further example, the following control parameters have beenestablished for suture tension and heat tipping of silk sutures sizes2/0, 3/0 and 4/0. In the following table the left column listscommercial needle types, the next column needle sizes, the next columnsuture sizes, the next column suture tension in grams applied by thetension roller 314, the next column tipping dwell time, the next columntipping heated air flow in standard cubic feet per minute, and the rightcolumn suture tipping temperature.

    ______________________________________    SILK SUTURE AND TIPPING PARAMETERS                           Suture              Tipping           Wire            Tension                                 Tipping                                        Tipping                                               Tem-    Needle Size    Suture  (grams)                                 Dwell  Air Flow                                               perature    type   (0.000")                   Size    (±10                                 (seconds)                                        (SCFM) (°F.)    Tolerance           N/A     N/A     grams)                                 (±0.020)                                        (±5)                                               (±15)    ______________________________________    CT-1   39      2-0     275   0.380  190    300    CT-2   39      2-0     275   0.380  190    300    SH     26      2-0     275   0.380  190    300    SH     24      3-0     275   0.380  190    300    SH     22      4-0     275   0.380  190    300    SH-1   22      3-0     275   0.380  190    300    SH-1   18      4-0     275   0.380  190    300    ______________________________________

The previous tables are for braided VICRYL suture and silk suture, andsimilar tables could be developed for other suture materials such asEthibond® (braided polyester) and monofilament and braided nylon.

The suture drawing, tipping and cutting is more completely described inU.S. Ser. Nos. 08/804,478, 08/803,573, and 08/804,477, all of which areentitled "Suture Cutting System," the disclosures of which areincorporated herein by reference thereto.

The Swage Dial Drive Assembly

The drive assembly for the swage dial 150 is illustrated in FIGS. 7a, 7band 8. As illustrated in FIG. 7a, the swage dial assembly 150 includes aswage dial 110 and a cam dial assembly 120 both of which areindependently driven by the drive means of the present invention. Adrive motor 140 drives both of these dials through a first indexingdrive transmission 142 and a second indexing drive transmission 144(illustrated in 7b) through a 90° reduction transmission 141 and arecoupled together with a timing belt 143. The indexing drive assemblies142,144 are "CAMCO" Indexer Drivers Model 350RGD 4H24-360 with a 10 to 1reduction in transmission 141 and an oscillation motion for the cam dialassembly 120. As will be hereinafter explained with respect to FIGS.10-11, the first indexing CAMCO drive includes 180° of drive and 180° ofdwell for every revolution of the transmission drive 141 which resultsin a 90° drive dwell cycle for the first indexing drive 142. The firstindexing drive 142 drives shaft 130 about a single drive axis D--D'illustrated in FIGS. 7-8. It is journalled for rotation in bearings131a,b,c, and d and is secured in place by drive cap 132 and acompression drive collar 133 which is connected to the output of thefirst indexing drive 142. A modular frame assembly 134 supports each ofthe drive elements about the central drive axis D--D'.

The second indexing drive 144 also includes 180° of drive, a second 60°of drive, a 30° dwell, a 60° drive and a 30° dwell for each revolutionof the input drive from belt means 143, and the indexing drive 144 isphased with the drive and dwell cycles of the first drive 142. As willbe hereinafter described with respect to FIGS. 10 and 11, during eachdwell period of the swage dial 110, the cam dial assembly 120 is held ina dwell position and then rotated to enable radial reciprocation of theuniversal grippers with respect to the swage dial 110.

The cam dial assembly 120 is mounted on an annular drive collar 135which connects the output of the second indexing drive 144 to the camdial plate 120 as more fully illustrated in FIG. 8. The annular drive135 is journalled for rotation on drive shaft 130 by means of needlebearings 136 to provide a single drive axis D--D' for rotation of theswage dial assembly 110,120. The annular drive collar providessuspension support and rotational drive for the cam dial assembly 120.The use of this annular collar also separates the cam dial and swagedial from the drive apparatus and enables operator workspace foralignment of the apparatus and for part changes when necessary. Theannular drive collar 135 is bolted to the output drive flange of theindexing drive 144 as shone at 135(a).

The swage dial 110 is mounted for rotation on a ball detent clutch 114which is fixably attached to shaft 130 and enables breakaway rotationbetween clutch drive plates 112 and 114 in the event of a catastrophicjam. The clutch 114 and shaft 130 also provide suspension support androtational drive for the swage dial 110.

The annular cam drive 135 is bolted to the output of the second indexingdrive 144 as illustrated at 135a and thus provides for both suspensionsupport and rotation of the cam dial assembly 120. Likewise, thebreakaway clutch 114 provides physical support and rotational drive forthe swage dial 110 by virtue of its fixed mounting on shaft 130 at 114a.

The Swage Dial

The process for extending each universal gripper 155 for needleprocessing at each of the stations 100, 200, 400, and 500 will now beexplained. As shown in FIGS. 10(a), 10(b) and 10(c), each universalgripper 155 is connected to a reciprocating carriage 151 and a cam slide164. Cam followers 165(a),(b),(c) and (d) are mounted to a cam slide 164at one end thereof with the universal gripper at the other end. Camslide 164 is slidable within stationary guides 166,167 and is adaptedfor reciprocal movement when the cam follower 165 is actuated. In thepreferred embodiment shown in FIG. 11(a), cam followers 165(a)-(d) arerollers that fit within the cam track of a rotatable cam dial assembly120. Cam dial assembly 120 is shown in FIG. 11(a) as comprising a camdial plate 125 having a continuous cam tracks 160 which receives camfollowers 165(a)-(d) attached to universal grippers 155a,b,c, and 155d,respectively. Each cam follower 165 is positioned within the cam trackat each station for movement therein.

As illustrated in FIG. 11(a), cam dial 125 is positioned above swagedial 110 and mounted coaxial therewith. The cam dial 125 is rotatableabout a central axis and controlled by a separate rotary indexingtransmission as described previously so that it may rotate separatelyfrom the swage dial plate 110. The cam dial is driven in multiple driveand dwell cycles as previously explained, and the degrees of each phaseare diagrammatically illustrated in FIG. 11(a). FIG. 11(a) also showscam followers 165a-d in a first retracted position within the cam track160. When the dials are in this position, each of the reciprocatingcarriages and consequently universal grippers 155 are in their retractedposition as shown in FIG. 10(a) and 10(b) discussed above. To extend theuniversal grippers 155 in place at their respective stations, the camdial plate 125 is rotated in the clockwise direction with respect to theswage dial plate 110, as indicated by the arrow A in FIG. 11(a), forapproximately 25 to 45 degrees, forcing cam followers 165a-d in its camtrack 160 to move toward the periphery of the dial as shown in FIG.11(b). Consequently, each of the cam slides 164, reciprocating carriages151a, and the universal grippers 155 move to the extended position asshown in FIG. 10(c). To move back to its retracted position, the camdial plate 125 is rotated in the counter clockwise direction withrespect to the swage dial plate 110 for approximately 20 to 30 degrees,forcing cam followers 165a-d in the cam track 160 to move to theirretracted position (FIG. 11(a)). Consequently, the cam slide 164,reciprocating carriage 151a, and the universal gripper 155 move back tothe retracted position as shown in FIG. 10(b) and discussed above.

It should be understood that when cam dial plate 125 rotates withrespect to swage dial 110, each universal gripper 155 is either extendedor retracted by the cam track. Thus, the system is designed so that allprocesses performed at each station occur simultaneously and forapproximately the same duration of time when the universal grippers arein their extended position, for e.g., for needle pick-up, for needleswaging, or, for needle pull-testing.

When the universal gripper 155 is retracted, the needle engaged therebymay then be indexed to a different station for further processing. Toindex the needle to another station, both swage dial plate 110 and camdial plate 125 are rotated together for approximately 90 degrees toposition the universal gripper at the next station. For example, whenthe cam dial plate 125 and the swage dial plate 110 are simultaneouslyrotated 90 degrees counterclockwise in FIG. 10, the gripper 155 that hadreceived the needle at station is now indexed to station 200 for swaginga suture thereto. Similarly, after swaging, the cam dial plate 125 andthe swage dial plate 110 are simultaneously rotated counterclockwise sothat the armed needle at station 200 is indexed to the pull-testingstation 400 for pull-testing thereof. The operations performedconcurrently at each station about the swage dial increases throughputto provide an output of pull-tested armed surgical needles at a rate ofapproximately 40 to 60 per minute in the preferred embodiment.

Universal Gripper

As illustrated in FIG. 1, the rotatable swage dial assembly 150cooperates with four stations where simultaneous needle operations areperformed. In the detailed illustration of FIG. 10(a), the swage dialassembly 150 includes a swage plate 110 having four universal gripperstations 145a, 145b, 145c, 145d spaced equally thereon.

The swage plate 110 is rotatably mounted at a central hub 112 on a balldetent safety clutch 114 (illustrated in FIG. 8) and operable to rotateunder the control of a control system computer 46. In the preferredembodiment, a separate reciprocating carriage 151 is provided at eachuniversal gripper station of the swage dial assembly 150. For instance,as shown in FIG. 10(a), universal gripper station 145a includesreciprocating carriage 151a, while station 145b includes reciprocatingcarriage 151b, station 145c includes reciprocating carriage 151c, andstation 145d includes reciprocating carriage 151d. Mounted to eachreciprocating carriage 151a,b,c,d for retractable movement therewith, isone universal gripper 155, two of which are shown connected to grippermounts 150(a) and (d) in FIG. 10(a).

As previously mentioned, each reciprocating carriage 151a,b,c,d anduniversal gripper 155 connected thereto is movable from a retractedposition to an extended position. When the gripper 155 is in theretracted position shown in FIG. 10(b), the needle 39 may be conveyed toa different station as the swage dial rotates; when the gripper 155 isin the extended position as shown in FIG. 10(c), the needle is in one ofthe active stations, such as the automatic swaging station.

The universal gripper of the present invention receives the needle fromthe precision conveyor and moveable hard stop mechanism, and transportsthe needle through the swage operation in which a suture isautomatically inserted into the barrel end of the needle, and the metalof the needle swaged about the suture. As can be appreciated, when theopening in the barrel is only 0.0106 and the suture diameter is 0.0088,a high degree of precision handling is required, particularly so whenthe insertion and swage operation need to be completed in approximately0.5 seconds in order to maintain a 30 to 60 needle per minute cyclerate. The universal gripper also transports the needle through the pulltest station in which the suture bond is tested and to the packagingarea, where the armed suture (needle and suture assembly) is bundledwith other armed sutures for future packaging.

In FIGS. 14(a)(b) and (c), both the slide portion 164 and the gripperportion of the universal gripper 155 are illustrated, with a pair ofneedle gripping jaws 146 and 148, each having a portion of a needlereceiving indent 157 formed therein. Each of the jaws have a reciprocalslide portion 146(a), 148(a) formed as an integral part, which slidesreciprocate in a channel 162 formed in housing member 174, The jaws 146and 148 are biased to each other and to a closed position by a springmember 160. The jaws are opened by a pair of moveable pivot linkages166, 168 which are mounted to and actuated by plunger 170, so that whenplunger 170 is depressed, the linkages 166, 168 are moved outwardly,drawing the jaws 146 and 148 with them. The plunger 170 is actuated by acam driven by an air motor at each automatic station to open and closethe jaws about a needle 39.

In the apparatus, a plurality of universal grippers are employed,preferably 4, each of which grips a single needle at positioning, atswaging, at testing and at off-load, as previously described. As theuniversal gripper is moved into position, the jaws 146,147 are openedand the gripper is reciprocated towards the needle so that open jaws arepresented on each side of the needle. The jaws of the precision conveyorboat 70 are then opened, and during transfer, the needle rests on themoveable hard stop 96. The jaws 146,148 of the universal gripper arethen closed to grip the needle and the moveable hard stop 96 isreciprocated out of engagement with the needle, and away from the jawsof the precision conveyor to allow the precision conveyor to advance thenext needle into the needle transfer position.

The step of loading of the individual precisely oriented surgical needle39 from the precision conveyor boat 70 and the moveable hard stop 96onto the universal gripper 155 at the precision loading station 100involves a compound movement on the part of the universal gripper. Sincethe needle is gripped in detents formed in the jaws of the conveyor boat70, and since one of the jaws of the precision conveyor boat 70 isfixed, it is necessary for the universal gripper to transcend a compoundmovement when removing the needle from the conveyor boat jaws. If astraight reciprocal movement is attempted, the needle is stripped fromthe jaws of the universal conveyor by the detent in the fixed jaw of theconveyor boat 70. This compound movement is found at both the precisionposition station 100 and the swage station 200, which also uses fixedand moveable jaws. The use of a fixed jaw substantially improves theaccuracy of the alignment of the needle with the suture at the swagestation.

In the frontal view of the universal gripper as shown in FIGS. 15(a) and(b), jaws 146 and 148 of the universal gripper 155 extendperpendicularly from the gripper to engage the barrel end 44 of thearcuate needle 39.

FIGS. 15(a),(b) also illustrates two roller cam surfaces 172, 180 whichact on the universal gripper. A cam surface 172 is found at each of thefour stations,(Precise positioning, swage, test and off-load) and isused to open jaws 146 and 148 of the universal gripper at each station.FIGS. 7 and 8 also illustrate three pneumatic drives 176(a),(b) and(c)which actuate rollers 172(a),(b) and (c) to open and close the jaws ofthe universal gripper 155 as will be hereinafter explained in greaterdetail.

FIG. 8 illustrates a typical positioning for cam 172 above the needlepull test station, wherein cam roller 172(a) is mounted on a bell crank174, which is actuated by an air cylinder 176(a). The cam 172(a) isnormally biased to a non-engaged position by spring 178.

Each of the universal grippers 155 is mounted for linear movement withrespect to the cam slide 164 by means of an off-set slide assembly, thedetails of which will be explained as with respect to FIGS. 14(a), (b)and (c). As indicated therein, the housing 174 of the universal gripperis mounted on a mounting block 175 and slide 177, and slide 177 isspring biased to a home position during reciprocation within slidecarriage 151 by spring member 179. This second reciprocal movement istransverse to the reciprocal movement imparted by cam slide 164.

Referring to FIG. 15(a),(b), roller cam 180 is used to provide thecompound off-set movement of the universal gripper as it is reciprocatedoutwardly by the swage dial cam plate 125. FIG. 10(a) illustrates atypical positioning for the off-set drive used to drive cam roller 180at the precise positioning station 100. Roller cam 180 is mounted on alinear slide 182, which is driven by an air motor 184, mounted on theswage dial frame. FIG. 10(a) also illustrates the relative motions ofthe universal gripper 155, with arrow A indicating the off-set movement,arrow B indicating the reciprocal movement which results in the radialreciprocation of the universal gripper 155 to 155a in FIG. 10(a), andarrow C indicating the rotary motion of the swage dial 110.

To accomplish the transfer of the needle to a universal gripper 155, theuniversal gripper 155 is extended and translated horizontally so thatthe face of the universal gripper is adjacent to the needle precisionconveyor boat 70 as shown in FIG. 8 and 10(a). In this position, thejaws 146 and 148 penetrate the plane of the needle 39 on either sidethereof. A load solenoid or similar device depresses a pusher arm of theprecision conveyor boat 70 to release the needle from the engagementjaws 77,79 of the precision conveyor boat 70 so that it rests on themovable hard stop assembly between jaws 146 and 148 of the universalgripper 155. Simultaneously therewith, as controlled by the controlsystem computer, jaws 146 and 148 are actuated from the non-engagingposition to an engaging position to thereby engage the needle 39 in anoriented position as shown in FIG. 15(a). The universal gripper 155 isthen off-set horizontally and retracted radially and the swage dialassembly 150 is rotated to the swaging station 200 to accomplishautomatic swaging of the suture to the needle 39.

Needle Swaging Station

The swaging operation taking place at the swaging station will now bedescribed with reference to FIG. 12, FIGS. 15(a)-(b) and FIGS.19(a)-(c). FIGS. 15(a)-15(b) illustrate the universal needle gripper 155and swaging and suture alignment dies shown in two stages of the sutureinsertion and needle swaging sequence. This sequence, and theinteraction of the dies in relation to each other, the needle, and theinsertion of the suture, accomplish the insert and swage function withminimal parts changes for each group of needle diameters and simplemotions.

After conveying the needle to swaging assembly 200 shown in FIGS. 12 and15(a), the universal gripper 155 is radially extended from the swagedial, and off-set to the side in the manner described above to positionthe suture receiving end 44 of needle 39 between the funnel shaped dieopening formed at the ends of two swage dies 273,274 as shown in FIG.15(a). As will be explained, swage die 274 is relatively fixed inposition and swage die 273 is movable laterally toward the fixed swagedie 274, as indicated by the arrow "A", to accomplish swaging of thesuture receiving end of a needle placed therebetween. A funnel shapeddie opening having an exit diameter slightly larger than the diameter ofthe suture receiving end 44 of the needle is formed when the two swagedies 273,274 are positioned adjacent each other as shown in FIGS. 15(b).

In the preferred embodiment shown in FIGS. 19(a) and 19(b), the ends ofeach of the swage dies 273,274 are provided with rectangular diecavities 283,284 respectively, to permanently swage the suture to needle39. Note that as illustrated in FIGS. 19(a),(b), The swage dies are fora small 18 mil needle, and FIG. 19(a) has been magnified 2× and FIG.19(b) magnified 100× for purposes of illustration. Different sets ofswage dies may be provided, depending upon the size (diameters) of theneedles and sutures to be swaged, and in the practice of the presentinvention, dies for needles ranging from 18 mil (0.018) to 50 mil(0.050). The die cavities illustrated in FIGS. 19(a),(b) are rectangularin shape with a 90 degree angle, and used to impart a permanent swagebond between needle and suture. Similar dies may be used with round diefaces to impart a controlled release swage bond between the needle andsuture.

To precisely position the suture receiving end 44 of needle 39 betweenthe swage die opening formed at the ends of two swaging dies 273,274,the movable swage die 273 is temporarily moved apart. In theillustration of the swaging assembly 200 shown in FIG. 12 and 15(a),swage die 273 is moved apart from the fixed swage die 274 by actuatingair cylinder 295 to provide a force upon cylinder rod 293 to enableswage die operating lever 205 to pivot about pin 206 and pull aretraction arm 297 which engages stud 298 affixed to moveable swage die273 a predetermined distance away from the fixed swage die 274. In thepreferred embodiment, lever 205 is biased by spring 209 so that themovable swage die 273 will return toward the fixed swage die by thespring restoring force when the pressure provided by the air cylinder295 is terminated.

FIG. 15(a) shows die 274 in its fixed position, and moveable die 273 inits spaced apart position prior to receiving the surgical needle 39presented by universal gripper 155. Suture alignment die 270 containingsuture guide funnel half 270(a) is positioned under swage die 273, andfree to slide laterally within limits. Suture alignment die 270 has atang 270(b) that protrudes into cavity 273a formed within swage die 273.Compression spring 273c bears against the back wall of cavity 273a andtang 270(b) such that funnel die 270(a) slides forward until it isconstrained by the inner wall of cavity 273(a). In this position, it isforward of the center axis defined by the suture receiving end of theneedle, and serves as a shelf that helps assure suture receiving end 44of needle 39 is in position for swaging. In this stage of the cycle, theparts are not positioned for suture insertion, and suture clamps365(a),(b) gripping suture 304 and stiffened end 358, are in dwell.Suture alignment die 271, containing funnel half 271(a), is fastened toswage die 274 by suitable fastening means.

While the swage dies are apart, the universal gripper 155 is extended toposition the suture receiving end 44 of needle 39 within the swageopening as shown in FIG. 15(a). Referring to FIG. 12, the universalgripper is off-set during entry and egress by cam roller 180(b), whichis driven by air cylinder 216 through bell crank 218. This off-set isnecessary to allow the needle to box step into the swage die opening 284in the fixed swage die as it is placed in position by the universalgripper 155. After positioning the suture receiving opening 44 of needle39 at the swage die opening 284, the moveable swage die 273 is movedtoward needle 39 with the resilient spring force present in spring 209that is sufficient to enable the dies 273,274 to grip and locate thesuture receiving end 44 precisely against fixed swage die 274 withoutdeforming the cavity of the suture receiving opening 44 formed therein.Concurrently, the jaws 146,148 of universal gripper 155 are opened bydownward external force on plunger 170, by cam roller 172 as describedabove, thereby releasing the needle so that its position is determinedby the grip of swaging dies 273 and 274. The motion of dies 273 and 270causes the face of suture alignment die 270 to come in contact with thecorresponding face of suture alignment die 271. The resilient forcecausing this motion is forceful enough to compress spring 273c, and movefunnel die 270(a) to the left, such that tang 270(b) is no longer incontact with cavity wall 273(a). Dimensioning of dies 270 and 271 issuch that this motion results in the formation of two funnel halves270(a) and 271(a) defining a smooth conical shape that is coaxial withthe suture receiving end 44 of needle 39.

FIG. 15(b) illustrates suture grippers 365(a),(b) moved vertically tothe insertion position, which causes stiffened suture end 358 to enterthe funnel defined at 270(a), 271(a), and be guided into the suturereceiving cavity 44 of needle 39 axially aligned therewith. Note thatthe exit diameter of the conically shaped funnel guide formed of funnelhalves 270(a) and 271(a) is preferably equal to or greater than thediameter of the suture tipped end 358 and smaller than the diameter ofthe suture receiving end 44 of the needle 39, so that the tipped end 358of the suture strand may be easily inserted therein. An enlarged detailof the suture alignment dies 270,271 and the placement of the funnelportions 270(a) and 271(a) is illustrated in FIG. 19(c). Once the strandis inserted into the suture receiving end 44 of the needle (step 27) asdiscussed above, the automatic swaging of the suture receiving cavityoccurs.

In the preferred embodiment of the swaging assembly 200 shown in FIG.12, a pneumatic air cylinder 204 provides air pressure to actuate cam275 that bears on lever 205 to pivot about pivot point 206 and drive cam207 against the end of the moveable swage die 273 to thrust movableswage die 273 toward the fixed swage die to accomplish the swaging ofthe suture receiving end of the needle placed therebetween. Air pressureis supplied to the swage cylinder 204 via ports 266 under the control ofthe control system computer 46.

After the swage die 273 has been driven to a fixed stop by the swagecylinder, the suture receiving end 44 of needle 39 has been deformed tothe desired shape defined by the swage die contours, as illustrated inFIG. 19(b). As deformation takes place, the moveable swage die 273 comesto a stop as a swage stop post which is press fit into the moveableswage die 273 strikes a reference wall cross milled into the frame ofthe swage assembly. When the swage stroke is performed, the swagecylinder drives the die and post assembly to the left (in FIG. 12) untilit is positively stopped by the lower portion of post striking the wallof the cross milled groove in the assembly frame (located under swagedie 273 in FIG. 12). This stalls air cylinder 204, so that the stroke ofthe moveable right hand die assembly shown is always the same forrepeated cycles of the machine. In an alternative embodiment, both swagedies 273,274 may be movable towards each other to accomplish swaging.

In the preferred embodiment, the degree of swage compression imparted onthe needle, and resulting strength of grip by the needle on the suture,is adjusted by precise positioning of the fixed die 274.

As shown in FIG. 12, servomotor 214 rotates a swage adjust screw 213, bydriving a belt and reduction pulley on the end of swage adjust screw213. The pitch of the swage adjust screw 213 is selected to move asliding wedge 212 a small distance. The swage die 274 has acomplementary ramp angle 243 at the opposite end which bears on thewedge 212 to retract or advance the position of the swage die 274 aprecise distance proportional to the movement of the sliding wedge.Thus, the rotation of the swage adjust screw 213 and motion of thesliding wedge 212, results in transverse movement of the swage die 274to thereby finely adjust its fixed position. For example, when a largersuture is to be swaged to a needle, the position of the fixed die 274may be moved further away from the suture drawing axis so as to providethe desired amount of deformation when the swaging pressure is appliedto the needle by the movable swage die 273. In the preferred embodimentshown in FIG. 12, the control system computer 46 will send theappropriate signals to automatically direct the servomotor 214 to adjustthe position of the swage adjust screw 213, and hence, the position ofthe fixed die 274, in accordance with the pull-out test values of theneedle-suture bond as measured by automatic pull-test system asexplained in further detail below.

Specifically, appropriate control signals may be generated to direct theservomotor 214 to adjust the rotational position of the swage adjustscrew 213 in accordance with stored statistical results of thepull-testing occurring at the pull-test station. Automatic pull-testingof the armed needle is desirable to ensure that the upstream swagingdies are optimally positioned to avoid over-swaging the needle-suturebond and hence, preventing the likelihood of clip-off, and, to avoidunder-swaging the needle-suture bond to prevent the chance of pull-out.

Referring to FIG. 15(a), after the needle has been swaged to the suture,the universal gripper 155 closes jaws 146,148 on needle barrel end 44 asthe drive roller 172 is reciprocated out of engagement with plunger 170.Simultaneously therewith, the moveable swage plate 273 is retracted toenable movement of needle 39 by the universal gripper 155. Before theswage dial 110 is rotated, the offset drive cam roller 180(b) is againadvanced to bear against cam plate 186 and provide egress of the needle39 from the swage dye cavity in fixed swage plate 274. Once theuniversal gripper 155 and needle 39 have cleared the fixed swage plate,the cam dial assembly 120 is rotated advancing cam rollers 165 inwardlyto retract the universal grippers 155 in a radial direction and enablerotation of the swage dial 110.

Swage dial 110 then rotates the needle and suture assembly to a pulltest station for testing as described in U.S. Ser. No. 08/847,132,entitled "Pull Test Station for Permanently Attached Sutures," alsoassigned to the assignee of the present invention, the disclosure ofwhich is incorporated herein by reference thereto.

Off Load Dial Assembly For Needles and Sutures

The offload station 500 is more particularly illustrated and describedwith respect to FIGS. 17 and 18-18(b) in which a plurality of needlebuckets 502 are circumferentially arranged on a rotatable turntable 504to be indexed under the collection point 506 defined by an interceptaxis of a needle stripper 190 and the face of the universal gripper 155.As the needles are stripped from the universal gripper, they fall into aneedle collection bucket which collects the needle inside the bucket,and most of the suture outside the bucket.

One needle stripper assembly 190 is illustrated in FIG. 16, whichstripper includes a reciprocating stripping pin 192, which is springbiased inwardly by spring 193, and reciprocated outwardly by pneumaticmotor 194 to engage the needle to be stripped. The stripping assembliesare secured in position by means of a bracket 191 which is bolted to theframe of the apparatus.

The present invention includes a pair of needle strippers 190a,190b, thelocations of which are illustrated in FIG. 10(a) adjacent thecircumference of the swage dial plate 110. Needle stripper assemblies190(a),(b) are mounted to the frame of the stand alone swage machine bymeans of brackets 191a,191b to provide a longitudinal axis ofreciprocation for the needle stripping pins 192a,b that is tangential tothe circumference described by the face of the universal grippers 155.When the needle stripper pins 192 are retracted, as illustrated in FIG.16, the universal gripper passes the needle stripping station withoutengagement. However, when the needle stripping pins are reciprocatedoutwardly, they intercept the path of needle 39 and are positioned toreciprocate into a space 188 (illustrated in FIGS. 14(b) and 15) definedbetween the face of the universal gripper 155 and the needle 39.Simultaneously therewith, the plunger 170 on the universal gripper isdepressed by one of the offload cams 172 to open the jaws 146,148 of theuniversal gripper and enable the needle to be stripped from theuniversal gripper.

One needle stripper is used at the pull test station to remove needlesthat have failed the suture pull test, and a second is used at the offload station to insure a positive removal of the needle and sutureassembly from the universal gripper at the off load station.

The needle stripper assembly 190(a) illustrated in FIG. 10(a) is used toremove needles that have failed the pull test at the pull test station400. The needle stripper assembly 190(b) is used to remove the needleand suture assembly from the universal gripper for bundling in theoffload station 500.

The needle bucket of the present invention is illustrated in FIGS.18-18(b), wherein FIG. 18 is a side view illustrating the a side view ofthe bucket and the radial reciprocation of the needle bucket, with FIG.18(a) illustrating a front view of the bucket and FIG. 18(b)illustrating a top view of the bucket.

As illustrated in FIG. 18, dotted line axis A illustrates thecircumferential path of the needle in a horizontal plane, while carriedby the universal gripper, while axis B and C illustrate the the radialreciprocation of the universal gripper 155 mounted on the swage dial.The needle stripping pin 192b engages the needle at the intersection ofaxis A and C at intersect 506 causing the needle to drop into the needlebucket 502. The needle falls into the bucket with the suture draped overa comb-like face 520 which holds the suture and assists in preventingentanglement of the sutures when they are removed from the needlebucket. Most of the suture remains outside the bucket, and is capturedwithin a suture shroud 524, illustrated in FIG. 17. The suture shroud524 guides the unsupported end of the suture and prevents entanglementwith the moving parts of the apparatus below the circumferential pathdescribed by the universal gripper. In addition, a stream of deionizedair may be provided at this station to assist in the orderly collectionof the sutures following the swage assembly.

Each of the needle buckets includes a second comb-like surface 522 onone side of the bucket, and an upstanding extended wall portion 526 onthe far side of the collection bucket to assist in capturing any latedropping needles.

Each of the needle buckets 502 is spring mounted for radialreciprocation on turntable 504 by means of a spring loaded reciprocatingmount 508 which nominally biases the needle bucket 502 inwardly. Whenthe needle bucket has arrived at the offload position, the bucket 502 isreciprocated outwardly as illustrated in FIG. 186 by a pneumatic motor510 to the position 502b illustrated in FIG. 18.

FIG. 17 also illustrates a detector 514 which is focused on a reflectorplate 528 under the swage dial assembly 150 that is triggered by apassing suture to actuate the needle stripping assembly 190(b).

After a predetermined number of needle and suture assemblies have beencollected in the needle bucket 502, the needle bucket 502 isreciprocated inwardly by relaxing air motor 510 and the turntable 504 isindexed to position the next available needle bucket 502 under the offload station. While 12 offload buckets 502 have been illustrated in FIG.17(a), it is understood that a smaller number of buckets could be usedif desired.

After a needle bucket 502 has been filled with a predetermined number ofneedle and suture assemblies, and rotated to the position illustrated at502(c) in FIG. 17, the bundle of needle and suture assemblies may beremoved for subsequent handling and packaging.

As is readily apparent to one skilled in the art, many variations on theabove described embodiment are possible. The foregoing description isexemplary only and not to be construed as limiting the scope of theinvention, which is defined in the claims, as follows.

What is claimed:
 1. A needle threading and swaging apparatus forattaching a suture to a surgical needle having a suture receivingopening formed therein, said apparatus comprising:(a) a needlesingulating apparatus for receiving a plurality of randomly arrangedsurgical needles, said apparatus including a sliding surface forassisting an operator in singulating surgical needles for transfer to aprecise positioning apparatus; (b) a precise positioning apparatus forreceiving singulated needles from said needle singulating apparatus andprecisely positioning the singulated needle at a first predeterminedlocation; (c) a universal gripper for receiving each preciselypositioned and singulated needle at said first predetermined locationand indexing said needle in a predetermined orientation from said firstpredetermined location through successive locations for sequentialprocessing at subsequent predetermined locations, (d) a suture cuttingstation located at a second predetermined location for automaticallycutting an indefinite length of suture material to a definite length andautomatically inserting said suture into said suture receiving openingformed in said surgical needle; (e) a swage station for swaging saidsurgical needle to close said suture receiving opening about a free endof said suture to secure said suture thereto and form therefrom a needleand suture assembly,whereby unsorted needles and an indefinite length ofsuture material are formed into a plurality of oriented surgical needleand suture assemblies.
 2. The needle threading and swaging apparatusaccording to claim 1 wherein said universal gripper means includes anindexing means for rotating the gripper to each of said successivestations and means to impart a compound reciprocal movement from a firstretracted position to a second extended position at each of saidsuccessive stations.
 3. The needle threading and swaging apparatusaccording to claim 2 wherein said universal gripper means includes firstand second jaws for engaging said surgical needle, said jaws having afirst engaging position for engaging said surgical needle in a preciselyoriented position, and a second non-engaging position for releasing saidsurgical needle.
 4. The needle threading and swaging apparatus accordingto claim 2 wherein said universal gripper means is horizontallytranslated as it is reciprocated into a gripping position to enable saidjaws to grip said surgical needle in said oriented position.
 5. Theneedle threading and swaging apparatus according to claim 4 wherein saidindexing means conveys said needle to said second location with saiduniversal gripping means engaging said needle in said oriented position.6. The needle threading and swaging apparatus according to claim 1wherein said swage station includes first and second swaging die means,said first swaging die means having an end thereof defining a portion ofa swage die opening, and said second swaging die means having an endthereof defining another portion of said swage die opening, wherein saidsecond swaging die means is positioned next to said first swaging diemeans to form a swage die opening for receiving said needle from saiduniversal gripper.
 7. The needle threading and swaging apparatusaccording to claim 6, wherein said first swaging die means is fixed inposition and said second swaging die means is laterally movable towardand away from said first fixed swage die means.
 8. The needle threadingand swaging apparatus according to claim 7, wherein said first swagingdie means is relatively fixed in position and adjustable in positionbetween swaging to adjust the swage compression imparted to said needleduring swaging.
 9. The needle and suture threading and swaging apparatusaccording to claim 6 wherein said swage station includes a springbiasing means to provide a force sufficient to move said second swagedie toward said first swage die to grip the needle without deformingsaid suture receiving opening of said needle after receiving the needlefrom the universal gripper.
 10. The needle threading and swagingapparatus according to claim 3, wherein said second means located atsaid second predetermined location comprises:(a) a drawing frame, saidframe having at least one longitudinal member and defining a drawingaxis parallel thereto; (b) means for feeding a flexible indefinitelength suture strand to said drawing axis for drawing and cutting; (c)first and second gripping means for gripping said indefinite lengthsuture strand and drawing it along said drawing axis, said firstgripping means mounted for reciprocal movement on said at least onelongitudinal member; (d) means for cutting said indefinite length suturestrand; and (e) said second gripping means reciprocal to a startposition along said drawing axis and below said cutting means, whilesaid first drawing means is drawing said indefinite length suture strandto an insertion zone located a predetermined distance beyond saidcutting means,whereby said indefinite length suture strand is insertedwithin said suture receiving opening of said needle and cut to apredetermined length by said cutting means after said second grippingmeans has gripped said indefinite length suture strand at said startposition.
 11. The needle threading and swaging apparatus according toclaim 10 further comprising a computer control means for said first andsecond drive motors to draw said indefinite length suture strand to saidpredetermined distance beyond said cutting means.
 12. An apparatus asclaimed in claim 11 further comprising a moveable carrier mounted forselective movement along said drawing axis, said movable carrier havinga heating means for tipping said suture mounted thereon.
 13. The needlethreading and swaging apparatus according to claim 12 wherein saidcomputer control means further comprises at least one sensor means fordetermining the position of said moveable carrier.
 14. The needlethreading and swaging apparatus according to claim 10 wherein saidfeeding means further comprises means for automatically tensioning saidindefinite length suture according to a predefined suture type during atleast the drawing and cutting thereof.
 15. The needle threading andswaging apparatus according to claim 10 wherein each of said first andsecond gripping means further include retractable gripping elementshaving a first engaged position and a second retracted position, whereinone of said first and second gripping means traverses the drawing axison a draw stroke with gripping elements engaged, and the other of saidfirst and second gripping means reciprocates along the same axis withthe gripping elements retracted to avoid mechanical interferencetherewith.
 16. The needle threading and swaging apparatus according toclaim 12 wherein said means for heat treating a portion of saidindefinite length strand of suture material includes a means forimparting a predetermined tension to the indefinite length suture atsaid treatment zone to form a tipped portion in said indefinite lengthstrand.
 17. The needle threading and swaging apparatus according toclaim 16 wherein said heat treating means is mounted on said movablecarrier remote from said cutting means.
 18. The needle threading andswaging apparatus according to claim 17 wherein said heat treating meansis heating a portion of said strand at a position remote from said toallow for partial hardening of said suture prior to cutting thereof. 19.The needle threading and swaging apparatus according to claim 18 whereinsaid cutting means cuts said stiffened strand remote from said treatmentzone to create a suture strand of definite length supported by saidfirst gripping means and a suture strand of indefinite length supportedby said second gripping means, with stiffened portions above eachgripping means.
 20. A needle threading and swaging apparatus forattaching a suture to a surgical needle having a suture receivingopening formed therein, said apparatus comprising:(a) a universalgripper for receiving a surgical needle at a first predeterminedlocation and gripping said needle in a predetermined orientation fortransport through a plurality of successive locations for sequentialprocessing at said successive locations, (b) a suture drawing andcutting station located at a second predetermined location forautomatically cutting an indefinite length of suture material to adefinite length and automatically inserting said suture into said suturereceiving opening formed in said surgical needle; (c) a swage stationfor swaging said surgical needle to close said suture receiving openingabout a free end of said suture to secure said suture thereto and formtherefrom a needle and suture assembly, said swaging station having afirst swaging die fixed in position and a second swaging die which islaterally movable toward and away from said first fixed swage die toswage said surgical station; (d) an indexing means for rotating theuniversal gripper to each of said successive stations, said indexingmeans having first and second means which together impart a compoundreciprocal movement from a first retracted transport position to asecond extended processing position at each of said successivestations,whereby unsorted needles and an indefinite length of suturematerial are formed into a plurality of oriented surgical needle andsuture assemblies.
 21. The needle threading and swaging apparatusaccording to claim 20 wherein said first swaging die has an end thereofdefining a portion of a swage die opening, and said second swaging diehas an end thereof defining another portion of said swage die opening,wherein said second swaging die means is positioned next to said firstswaging die means to form a swage die opening for receiving said needle.22. The needle threading and swaging apparatus according to claim 21,wherein said first swaging die means is relatively fixed in position andsaid second swaging die means is laterally movable toward and away fromsaid first fixed swage die means to swage said surgical needle.
 23. Theneedle threading and swaging apparatus according to claim 22, whereinsaid swage die opening is axially aligned with said drawing axis at saidsecond predetermined position, with said universal gripper means in saidretracted position at said predetermined position prior to positioningsaid surgical needle within said swage die opening, and is extended andtranslated in said compound movement to position said suture receivingopening of said needle in said swage die opening prior to swaging. 24.The needle threading and swaging apparatus according to claim 23 whereinsaid third means for swaging further includes a funnel guide positionedat an insertion zone between a free end of said definite length suturestrand and said suture receiving opening of said needle, said funnel diemeans including a tapered opening axially aligned with said swage dieopening for directing said free end of said suture strand into saidsuture receiving opening of said needle positioned therein.
 25. Theneedle threading and swaging apparatus according to claim 24 whereinsaid funnel guide means further includes a registration means forresiliently aligning it with at least one of said first and secondswaging dies.
 26. The needle threading and swaging apparatus accordingto claim 25 wherein said funnel guide means includes a first fixedsuture alignment die having an end thereof defining a portion of saidtapered opening, and a second movable suture alignment die having an endthereof defining another portion of said tapered opening, wherein saidsecond movable suture alignment die is positioned next to said firstfixed suture alignment die to form said tapered opening.
 27. The needlethreading and swaging apparatus according to claim 26 wherein saidtapered opening has a suture exit diameter that is larger than thediameter of said suture strand and smaller than the diameter of saidsuture receiving opening defined in the needle.
 28. The needle threadingand swaging apparatus according to claim 27 wherein said first grippingmeans is advanced along said suture drawing axis to direct said free endof said suture strand through said funnel guide means and into saidsuture receiving opening of said needle positioned in said swage dieopening.
 29. The suture threading and swaging apparatus according toclaim 28 wherein said swaging station includes a drive means for movingsaid second swage die means laterally away from said first swage diemeans prior to positioning said needle within said swage die opening.30. The needle and suture threading and swaging apparatus according toclaim 29 wherein said drive means includes a spring biasing means toprovide a force sufficient to move said second swage die toward saidfirst swage die to grip the needle without deforming said suturereceiving opening of said needle when said surgical needle is positionedin said swage die opening.
 31. The needle and suture threading andswaging apparatus according to claim 30, wherein said drive meansincludes an air cylinder means for supplying adequate force to thrustsaid movable swage die toward said first swage die to accomplish swagingof said needle gripped therebetween.
 32. The needle and suture threadingand swaging apparatus according to claim 31, wherein said second swagedie means is thrust towards said first die means for a swaging stroke ofa predetermined distance to accomplish said swaging.
 33. The needle andsuture threading and swaging apparatus according to claim 32, whereinsaid drive means includes a stop for terminating the motion of saidsecond swage die during said swaging stroke.
 34. The needle threadingand swaging apparatus according to claim 20 wherein universal gripperfurther includes first and second jaws for gripping the surgical needle,wherein the jaws of the universal gripper are opened to a non-engagingposition for relaxing said surgical needle in said swage die openingafter gripping but before swaging thereof.
 35. The needle threading andswaging apparatus according to claim 20 wherein said swaging stationfurther includes means for adjusting the position of said first swagingdie to change the amount of swage deformation occurring to said suturereceiving opening during swaging thereof.
 36. The needle threading andswaging apparatus according to claim 35 wherein said first fixed swagingdie includes a wedge follower located at one end thereof, said means forchanging the position of said first fixed swaging die means including awedge assembly positioned to move transverse to said wedge follower tolaterally move said wedge follower and said first fixed swaging diemeans in accordance with transverse movement of said wedge assembly. 37.The needle threading and swaging apparatus according to claim 36 whereinsaid transverse movement of said wedge assembly is controllable by aservomotor means for rotating a swage adjust screw of a predeterminedpitch, said rotation of said swage adjust screw being translated intolinear motion of said wedge assembly.
 38. The needle threading andswaging apparatus according to claim 35 wherein a computer control meansdetermines and controls the optimum positioning of said first swagingdie to avoid over-swaging and under-swaging said needle.